Identity
- Trade Name
- SPECTRA EXAMINATION LIGHT SERIES FDA UDI
- Generic Name
- Mobile examination/treatment room light FDA UDI
- Device Name
- LED Examination Light; Ceiling, Wall, Stand, or Boom options FDA UDI
- Model / Reference
- AUT1S FDA UDI
- Description
- LED Examination Light; Ceiling, Wall, Stand, or Boom options FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736112028 FDA UDI
- FDA Product Code
- KZF FDA UDI
- GMDN Term
- Mobile examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mobile examination/treatment room light
Spectra Examination Light Series by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Skytron, LLC
Sources (1)
- FDA UDI ca1d383e-de6c-4dc3-9df4-24e3656ed198 35 fields · synced May 30, 2026